Table 4.

Overview of TEAEs

Parameter	Alogliptin 25 mg QD (n = 75)	Placebo (n = 76)	Total (N = 151)
Total number of AEs	205	226	431
AEs related to study treatment	20	21	41
Total number of SAEs	5	7	12
SAEs related to study treatment	0	0	0
Patients with any TEAE	60 (80.0)	58 (76.3)	118 (78.1)
Infections and infestations	28 (37.3)	26 (34.2)	54 (35.8)
Metabolism and nutrition disorders	17 (22.7)	23 (30.3)	40 (26.5)
Gastrointestinal disorders	15 (20.0)	17 (22.4)	32 (21.2)
Nervous system disorders	17 (22.7)	11 (14.5)	28 (18.5)
Investigations	11 (14.7)	11 (14.5)	22 (14.6)
Injury, poisoning and procedural complications	6 (8.0)	8 (10.5)	14 (9.3)
Skin and subcutaneous tissue disorders	5 (6.7)	7 (9.2)	12 (7.9)
General disorders and administration site conditions	9 (12.0)	2 (2.6)	11 (7.3)
Musculoskeletal and connective tissue disorders	5 (6.7)	6 (7.9)	11 (7.3)
Reproductive system and breast disorders	7 (9.3)	3 (3.9)	10 (6.6)
Respiratory, thoracic, and mediastinal disorders	5 (6.7)	4 (5.3)	9 (6.0)
Renal and urinary disorders	5 (6.7)	3 (3.9)	8 (5.3)
Psychiatric disorders	1 (1.3)	5 (6.6)	6 (4.0)
Immune system disorders	2 (2.7)	3 (3.9)	5 (3.3)
Blood and lymphatic system disorders	3 (4.0)	1 (1.3)	4 (2.6)
Vascular disorders	2 (2.7)	2 (2.6)	4 (2.6)
Cardiac disorders	1 (1.3)	2 (2.6)	3 (2.0)
Eye disorders	2 (2.7)	1 (1.3)	3 (2.0)
Ear and labyrinth disorders	1 (1.3)	1 (1.3)	2 (1.3)
Hepatobiliary disorders	1 (1.3)	1 (1.3)	2 (1.3)
Congenital, familial, and genetic disorders	1 (1.3)	0	1 (0.7)
Endocrine disorders	1 (1.3)	0	1 (0.7)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	0	1 (1.3)	1 (0.7)

All data values are presented as n (%) or n

AE adverse event, QD once daily, SAE serious adverse event TEAE treatment-emergent adverse event